Twelve Technical Specification Items under Article 11.4.1 of RTCR 505:2022

1. Key takeaways

Article 11.4.1 of the main technical regulation divides the technical specifications into twelve items, lettered (a) through (l). The applicant must provide the manufacturer’s original technical specifications, manuals and instructions for use, submitted in the form in which the product is commercialised in its home market; documents that are not in Spanish must be accompanied by the corresponding translation. These twelve items form the baseline documentation applicable to every Clase 2, Clase 3 and Clase 4 registration, and in practice they make up the largest portion of the Costa Rican dossier and attract the highest rate of deficiency requests.

• The specifications must be the manufacturer’s originals (originales del fabricante), not a version written by the distributor or the authorised representative.
• Item (g) asks whether the finished product is sterile; if it is, the sterilisation method must be stated together with a validation report for that process.
• Item (h) is a separate question: whether sterilisation is required before use and which method is used.
• The answer to item (i) on personal use feeds directly into the labelling duties of Articles 19.1.13 and 19.1.16.
• Item (l) requires safety data sheets (FDS) and the qualitative formulation for the solutions that accompany IVD reagents.
• IVDs must additionally submit the list of tests performed (11.4.2 b) and the test performance report (11.4.2 c).

2. Legal basis

The table below maps each element of the twelve-item list to its provision in RTCR 505:2022, together with the additional items that apply only to in vitro diagnostic devices under Article 11.4.2.

3. Expert insights

Insight 1. Article 11.4.1 demands the documents originales del fabricante — the manufacturer’s originals — not a version compiled by the distributor. Article 11.4 opens with the phrase Especificaciones técnicas y médicas originales del fabricante: the technical and medical specifications, manuals and instructions issued by the manufacturer. The practical meaning is that product descriptions assembled by the distributor or the authorised representative cannot simply stand in for them. The manufacturer’s original documents must be the backbone of the submission, with translations attached as supporting annexes rather than as replacements.

Insight 2. Items (g) and (h) address two different sterilisation questions and are frequently merged into a single answer, which is a mistake. Item (g) asks whether the finished product is sterile; if it is, the sterilisation method must be described and a validation report for that process (informe de validación de este proceso) must be submitted. Item (h) asks whether sterilisation is required before use, and by which method — this targets products delivered non-sterile and sterilised by the healthcare facility before use. The former requires a validation report, while the latter only requires a statement of method. Merging the two answers usually causes the validation report required under item (g) to be omitted altogether.

Insight 3. Item (i), whether the product is for personal use (de uso personal), is not a descriptive field but a classification marker that triggers downstream labelling duties. Article 19.1.13 requires the label to state whether the product is for personal use, and Article 19.1.16 makes it mandatory for IVDs for personal use to carry the statement Esta prueba de autocontrol es únicamente orientadora y no brinda un diagnóstico definitivo (this self-test is merely indicative and does not provide a definitive diagnosis). The answer given under item 11.4.1 i) therefore flows straight into label design and cannot be treated as an isolated field.

Insight 4. Item (l) reaches the solutions, not the reagents themselves. The provision targets the conditioning, cleaning and sterilising solutions supplied for use with IVD reagents, and requires their FDS (safety data sheet) and qualitative formulation. This is one of the points where chemical compliance requirements land inside the device dossier, and it is the item most often missed in IVD submissions — particularly when the solutions are supplied by a third party rather than by the reagent manufacturer itself.

4. Practical recommendations

• Use the manufacturer’s original technical specifications as the master document and answer items (a) through (l) one by one with matching numbering, avoiding narrative paragraphs that blend several items together.
• For sterile products, prepare the sterilisation method description and the validation report for that process together (item g); for products sterilised before use, a statement of the method is sufficient (item h).
• Carry the answer to item (i) into label design: products for personal use must carry the statements required by Articles 19.1.13 and 19.1.16.
• For solutions accompanying IVD reagents, submit the FDS and qualitative formulation under item (l); where the solutions are supplied by a third party, obtain the documents from that supplier.
• IVDs must additionally submit the list of tests (b) and the performance report (c) under Article 11.4.2.
• Attach the corresponding translation to every non-Spanish document (Article 11.4) and archive translations and originals together under a single numbering scheme.

5. Verification checklist

• □ Technical specifications are the manufacturer’s original documents (Article 11.4)
• □ Answers are numbered item by item from (a) to (l)
• □ Sterile products: sterilisation process validation report is ready (g)
• □ Products sterilised before use: method is stated (h)
• □ Personal-use determination has been carried into labelling (i → 19.1.13 / 19.1.16)
• □ FDS and qualitative formulation are ready for IVD companion solutions (l)
• □ IVD dossier additionally includes the test list and performance report (11.4.2)

Related reading: [Medical specifications six items: how to write intended use, complications and contraindications](/costa-rica-medical-device-registration/medical-specifications-six-items/) | [IVD additional technical specifications and the accuracy and precision standard](/costa-rica-medical-device-registration/ivd-technical-specifications-and-accuracy-standard/) | [Clase 2 route: panorama of the eleven dossier requirements](/costa-rica-medical-device-registration/class-2-dossier-eleven-requirements/)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com